What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Contribute to continuous improvements in overall product cost and quality.
- Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.
- Collaborate with Quality Engineering to provide manufacturing support.
- Create standardized work and process maps that result in an optimized production system and extended value stream.
- Support line validation / qualification activities for including IQ, OQ, MSA and PQ.
- Perform root Cause Analysis (RCA), Client and CAPA responses.
- Need to conduct qualification, verification, and validation activities to produce medical devices.
- Work with CFT teams in troubleshooting problems on the production floor.
- Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.
- Drive the execution of various validation and PFMEA activities as per the project plan
- Application of statistical and analytical methods such as SPC, SQC and DOE.
- Contributor to the Capital Expense Request (CER) process, specify cost for Packaging/Libelling/ sealing equipment with consideration to product standard cost targets and capacity demands.
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client's and CAPA.
- Execute Site acceptance test and Factory acceptance test based on North Haven.
- Execute Validation Gap analysis of various product families based in Healthcare
- Plan and initiate CDPs associated with the various validation activities.
- Co-ordination with stakeholders.
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client's and CAPA.
- BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering.
- Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.
Salary : $71,600 - $92,500
